In the United States, one of the richest and most technically advanced nations on earth, millions of couples remain involuntarily childless. A conservative estimate places the number of U.S. couples that grapple with infertility annually at 5,000,000, yet less than 20% of those couples will undergo some form of definitive treatment. The high cost of infertility treatment, especially the advanced Assisted Reproductive Technologies (ART) such as In Vitro Fertilization (IVF), has resulted in reluctance on the part of most insurance companies to provide benefits for infertility and therefore, has rendered such medical intervention financially inaccessible to the general infertile population. Although a few states have enacted legislation requiring health insurance providers to offer or provide infertility benefits, such coverage is often limited, or absent altogether due to regulatory loopholes. The majority of employer groups as well as health insurance providers continue to avoid voluntarily including infertility benefits. They recognize that such benefits would spawn an increase in the demand for these specialized services. This fuels their fear of the spiraling costs that might be brought about by a disproportionate increase in the demand for expensive ART, and the costly neonatal services required to deal with the potential influx of premature babies resulting from IVF-related multiple births.
These facts not withstanding, it is inevitable that the strong and rising tide of consumer demand in response to compelling scientific evidence in support of IVF and other non-experimental ART’s as valid treatment options for a legitimate disease, will ultimately force a much needed change. It is our contention that unless medical and insurance providers abandon the existing stalemate and work together to reach agreement that leads to the rapid introduction of voluntary, universal insurance benefits for infertility, including ART, there will occur a rising tide of consumer discontent that will become a catalyst for a government-imposed resolution. It would be preferable by far for medical and insurance providers to commit to working in unison to resolve this problem, rather than having heavy-handed bureaucratic legislation thrust upon us. The development of a strategy that would enable insurance providers to control costs and quality by monitoring utilization and treatment outcome, while discouraging abuses of the system, could put voluntary universal infertility insurance coverage well within reach.

Background 
Historically, the insurance industry has resisted the provision of voluntary infertility benefits on the basis of the following: 
(1) lack of accountability in reporting of ART/IVF success rates, 
(2) fear of precipitating adverse enrollee selection, 
(3) the significantly high incidence of high-order multiple births (triplet pregnancies or greater) and the associated medical costs and social consequences and, 
(4) significant disparity in success rates among ART programs. 

1) Lack of Accountability in Reporting IVF Success Rates 
The field of ART, which involves in vitro fertilization and related procedures, has repeatedly been the focus of heated debate and controversy. Is this due to the fact that this area of medicine that deals with the initiation of life is regarded as sacrosanct, or is it because the practice of ART is so prone to misrepresentation and lack of accountability that it is regarded by many as fraudulent? Why is it that a couple researching their chances of undergoing successful IVF in two different ART clinics in the United States will often find that the live birth rate in one center is 2-3 times higher than in the other? And why, with a reported national average birth rate for IVF in women under age 39, using their own eggs, of about 30% per egg retrieval procedure, do these couples encounter outcome statistics that range from single digits in alleged poor programs to more than 50% in better ones? Making matters worse, why, when turning to professional medical oversight bodies such as the Society for Assisted Reproductive Technology (SART) and the Center for Disease Control (CDC) to answer these questions and help them identify and select an IVF program on the basis of its proven track record, do consumers find themselves stone-walled?…Because there is currently no verifiable system of outcome-based IVF reporting in America. Furthermore, the current practice by SART of reporting conventional IVF statistics under a single broad category–the woman’s age–is of little value to the individual IVF candidate. The multitude of variables that influence IVF outcome renders any attempt at interpreting IVF outcome based upon such a broad generalization misleading, and possibly even deceptive. Despite sixteen years of repeated promises to implement verifiable reporting of clinic-specific IVF success rates, SART’s current system of “quality assurance” falls far short of achieving this objective, and as such, does not protect the consumer from manipulation. 
The current criteria for clinic-specific reporting by SART-member programs are unenforceable. For the most part, the SART report consists of self-generated data submitted by ART programs and published unaudited and/or unvalidated, largely upon the basis of “good faith”. In the virtual absence of oversight and accountability, it is a relatively simple matter for any IVF program to overstate their number of IVF “successes”, understate their number of “failures”, and/or “improve” their success rates by selectively performing IVF on only those cases most likely to succeed (e.g., younger women, women with few or no prior IVF failures, and women who, based upon testing, are most likely to respond optimally to fertility drugs). Given that the practice of IVF in the United States is highly competitive and consumers understandably prefer to undergo treatment at the most successful centers, it should come as no surprise that with little or no risk of being detected and minimal consequences if they are, some IVF programs do indeed overstate their success rates. 
A historical perspective may provide further insight. SART was originally established in New Orleans at the annual meeting of the American Fertility Society in 1984. At that time it was perhaps more aptly named the “IVF Special Interest Group”. For several years it was the policy of the IVF Special Interest Group to annually report only pooled data, i.e., the collective results of its entire ART-program membership. In fact, each member program that submitted its annual statistics for inclusion in what was then known as the IVF Registry was given assurance by the custodians of the Registry that only pooled data would be made public. Further, Registry members were actually advised not to disclose their clinic-specific outcome data based upon the belief that it would make it less likely that IVF programs would overstate their success rates in order to be competitive. 
In 1986, responding to numerous complaints regarding exploitation and unscrupulous practices in the arena of infertility in general, and IVF in particular prompted the United States Congress took action. Hearings were held under the auspices of the Office of Technology Assessment (OTA) to address consumer concerns. In 1989 the proceedings and the conclusions were published in the “Wyden Report”. Congress subsequently mandated, under threat of prosecution, that all IVF programs in the United States report their outcome statistics for 1987 and as a result, the first report of clinic-specific ART outcome statistics in the United States was published. This was followed by passage of the “IVF Success Rate Certification Act of 1992” which was implemented in 1997. The explicit intent of this act was to compel honest disclosure of IVF success rates and the implementation of quality assurance in all IVF programs in the United States. 
In 1994, sensing a growing consternation among IVF consumers regarding its continued non-accountability, SART gave tacit support to the introduction of an “audit” of all its member programs. The national accounting firm of Peat Marwick & Company was engaged to develop and help implement a clinic-specific, IVF-outcome based reporting process. Disinterest on the part of ART centers, coupled with SART’s lack of resolve to enforce compliance, resulted in this attempt at a verification process being abandoned before the year ended. Perhaps not unexpectedly, subsequent gestures on the part of SART to introduce alternate methods for the appropriate verification of IVF outcome reporting have led to nothing more than the virtual “self reporting process” that currently exists, and which is supported by “token” random and sporadically conducted onsite reviews. The ultimate complete failure of this process became self evident in July, 2002, when SART sent a letter to all IVF Program Directors in the U.S. stating that as a result of a “lack of financial and human resources”, random onsite reviews would be foregone with respect to outcome data for the year 2000. Instead, SART directed all Medical Directors of its member programs to perform a specified “self-review” of the medical and laboratory records of ten (10) pre-selected IVF cases. Upon receipt of such information in the required format, the center would pass certification and thereupon would undertake to publish the program’s total, self generated IVF outcome data for the year 2000 on the Center for Disease Control’s (CDC’s) official web site. 
As long as SART refuses to demonstrate a commitment to fulfill their obligation to assure honesty in reporting of IVF outcome data, the insurance industry will likely remain skeptical and reluctant to pay for IVF.

Fear of Adverse Enrollee Selection 
There is concern on the part of individual insurance companies and employer groups that a decision to provide benefits for ART would cause infertile couples to take rapid, excessive, and possibly ill-advised advantage of the coverage and ultimately result in an unreasonable financial liability. In this report, we will demonstrate that the implementation of a reporting system based on outcome (the Outcome Based Reporting System-OBRS) will work to avoid these concerns. We will show further that this approach will serve to minimize risks to insurance companies and actually work to help them to enroll otherwise healthy families, whom it is anticipated will become loyal members for a substantial period of time into the future. 

High Incidence of IVF-related Multiple Births 
In an attempt to optimize success rates, many IVF programs in the United States still transfer relatively high numbers of embryos with the hope that at least one will result in a pregnancy. The result has been an unacceptable increase in the incidence of high-order multiple births. High-order multiple pregnancies, because they compound the incidence and severity of most pregnancy-induced complications and are associated with a high risk of premature delivery, are prejudicial to the health of both the mother and her offspring. Premature birth leads to a high perinatal mortality and morbidity with complications that can prevail throughout the life of the offspring. Such prematurity-related, life-long morbidity establishes an enormous potential financial burden for insurance providers and thus creates a strong disincentive to provide benefits for ART services. Although the ASRM has published guidelines relating to the numbers of embryos to be replaced in a given patient, there is currently no reasonable method to mandate the maximum number of embryos that may be transferred. Consequently the insurers have no control over this variable. This problem can only be solved through penalizing IVF providers whenever a high-order multiple pregnancy occurs as the direct consequence of transferring an inappropriately high number of embryos. 

Disparity in IVF Success Rates 
The wide disparity in IVF success rates reported by ART programs in the United States has understandably led providers of health insurance to question and investigate the varying levels of expertise with respect to these services. This disparity in IVF success rates, coupled with an awareness that there is currently no way of accurately verifying reported success rates, has eroded confidence in the entire ART industry and has contributed to reluctance on the part of insurance companies to fund such services. 
In those states that mandate IVF coverage, leaving insurance payors with little choice but to comply, costs have spiraled out of control and have led to a progressive reduction in the reimbursement for IVF services. ART programs have been forced to respond by increasing their productivity in order to remain profitable. To achieve this, many physicians have “cut corners” by involving more paramedical and/or technical personnel in the performance of procedures that they themselves would ordinarily do (e.g., such as ultrasound monitoring of follicle growth)–and by devoting less time to the individual patient. Predictably, such actions have led to a decline in the standard of care and reduced IVF success rates. 
The time has come for an immediate commitment to solve this problem, otherwise heavy-handed bureaucratic legislation and regulation is bound to be thrust upon us? The development of a strategy must include development of a verification process that would permit real monitoring of IVF utilization and outcome. One that rewards for good performance in terms of outcome in well defined categories of clinical complexity (so as to allow outcome to be evaluated in comparable patients), discourages and penalizes abuses of the system, including but not limited to the reckless transfer of large numbers of embryos, and does all this in real time providing easy access of results to all interested parties (consumers, governing bodies and insurance providers). If this is done, universal IVF insurance coverage could well become within reach since there could be a significant financial upside for insurance companies, through tapping into the large infertility community. Remember, aside from reproductive problems, the infertile population in the United States is relatively young and healthy, comprising individuals, who are less likely to require costly medical care and whose need to keep their insurance coverage current at all times, would likely ensure their being fiscally responsible. Moreover employers could offer access to infertility coverage as an added benefit, by which they could attract high quality employees. 
The first step towards attaining the worthy objective of universal infertility coverage requires introduction of a method that will allow for reliable verification of clinic-specific outcome data (birth rates per cycle of treatment) for every possible demographic category. A computerized data collection system could be placed in every participating ART program, with the requirement that only those procedures that are fully entered within 72hrs of completion would be eligible for insurance reimbursement. This would permit accurate and verifiable outcome reporting along with oversight relative to the number of eggs/embryos being transferred. All ART programs could be required to meet specific performance standards in order to qualify for insurance reimbursement and be rewarded and/or incentivised financially if performance exceeded required standards. In this way, by shifting the focus from service to outcome, there would evolve a strong incentive to upgrade standards of care, improve outcomes and minimize the number of treatment cycles necessary to achieve a live birth.
It imperative that health insurance providers be embraced as part of the solution rather than being part of the problem. An all-inclusive multi-institutional “Think Tank”, comprising physicians, consumers, and insurance providers should be convened without delay, to discuss the feasibility of introducing universal infertility insurance coverage in the United States. The goal must be to have the insurance industry join all interested parties in the immediate establishment and enforcement of a workable regulatory process. 
Change is sometimes difficult to accept and implement. It is anticipated that the novel approaches, will create anxieties and objections from established, albeit outdated and inadequate, data collection programs such as the ones currently in place and overseen by SART and the CDC. It is believed however, that it is time to take the cause for optimal, safe and affordable infertility care, to the ones who need it the most – the consumers. It is anticipated that approach outlined above, would create necessary checks and balances to provide cost-effective, voluntary, universal insurance benefits for advanced ART’s, with widespread and far reaching advantages for the employer, the pharmaceutical companies, the physicians and above all prospective and existing patients.